Sun Pharmaceuticals said the FDA has cleared its manufacturing facility at Dadra that had received a warning letter from the agency earlier this year.
Roche will lose protection on the so-called Cabilly manufacturing patents next year, and face the loss of more than $600 million in royalties.
Clinical care experts and patient advocacy organizations call attention to why better patient understanding shapes the best integrated approach to orphan drug…
Shortages of drugs produced in Puerto Rico are beginning to materialize after hurricanes Irma and Maria wreaked havoc on production on the island.
Sanofi will invest more than $200 million in a new plant in France to produce its newest flu vaccine, VaxigripTetra.
Brought to you by the publisher of FierceBiotech and FiercePharma, the Fierce Innovation Awards Life Sciences Edition identify and showcase outstanding…
Xellia Pharmaceuticals is investing $25 million to build additional sterile manufacturing capacity at its site in Copenhagen.
Pfizer has sold another Hospira plant, its second in eight weeks, this one a high containment API facility in Boulder, Colorado.
Indian CDMO Piramal Pharma Solutions is beefing up its global API production, including in the U.S., where it has expanded in recent years.
The FDA has issued Biocon and partner Mylan a complete response letter for their biosimilar of chemotherapy drug Neulasta tied to manufacturing.
Budding CDMO Avara Pharmaceutical Services has bought a solid dose facility in France from AstraZeneca, its third plant acquisition in three months.
Novo has filed a citizen petition saying Victoza’s manufacturing is so complex that equivalence of generics can't be certain without clinical trials.